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Clinical Trial Details

Trial ID: L6412
Source ID: NCT03770728
Associated Drug: Efpeglenatide Sar439977
Title: Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With Sulfonylurea
Acronym: AMPLITUDE-S
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03770728/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Efpeglenatide SAR439977|DRUG: Placebo|DRUG: Background therapy: Metformin alone or in combination with SU
Outcome Measures: Primary: Change From Baseline to Week 30 in HbA1c, This analysis included all Week 30 assessment values available., Baseline to Week 30 | Secondary: Number of Participants With HbA1c <7.0%, Participants who had no available assessment for HbA1c \<7% at Week 30 were considered as non-responders., Week 30|Change From Baseline to Week 30 in Fasting Plasma Glucose (FPG), This analysis included all Week 30 assessment values available., Baseline to Week 30|Change From Baseline to Week 30 in Body Weight, This analysis included all Week 30 assessment values available., Baseline to Week 30|Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], Severe Hypoglycemia), Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<54 milligrams per deciliter (mg/dL) (\<3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions., Baseline up to Week 30|Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL] and Severe Hypoglycemia) Per Participant-Year, Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<54 mg/dL (\<3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions., Baseline up to Week 30
Sponsor/Collaborators: Sponsor: Sanofi | Collaborators: Hanmi Pharmaceutical Company Limited
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 312
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2019-08-01
Completion Date: 2020-12-27
Results First Posted: 2021-12-02
Last Update Posted: 2021-12-02
Locations: Investigational Site Number 8400038, Birmingham, Alabama, 35211, United States|Investigational Site Number 8400035, Chandler, Arizona, 85224, United States|Investigational Site Number 8400005, Glendale, Arizona, 85306, United States|Investigational Site Number 8400042, Mesa, Arizona, 85206, United States|Investigational Site Number 8400051, Phoenix, Arizona, 85020, United States|Investigational Site Number 8400056, Tucson, Arizona, 85741, United States|Investigational Site Number 8400057, Huntington Park, California, 90255, United States|Investigational Site Number 8400009, Los Angeles, California, 90057, United States|Investigational Site Number 8400045, Spring Valley, California, 91978, United States|Investigational Site Number 8400040, Tustin, California, 92780, United States|Investigational Site Number 8400047, Colorado Springs, Colorado, 80909, United States|Investigational Site Number 8400046, Coral Gables, Florida, 33134, United States|Investigational Site Number 8400041, Pembroke Pines, Florida, 33026, United States|Investigational Site Number 8400025, Lawrenceville, Georgia, 30044, United States|Investigational Site Number 8400044, Lexington, Kentucky, 40503, United States|Investigational Site Number 8400001, Bridgeton, New Jersey, 08302, United States|Investigational Site Number 8400039, New Windsor, New York, 12553, United States|Investigational Site Number 8400036, Morehead City, North Carolina, 28557, United States|Investigational Site Number 8400013, Maumee, Ohio, 43537, United States|Investigational Site Number 8400048, Oklahoma City, Oklahoma, 73111, United States|Investigational Site Number 8400030, Dallas, Texas, 75230, United States|Investigational Site Number 8400043, San Antonio, Texas, 78229, United States|Investigational Site Number 8400037, Layton, Utah, 84041, United States|Investigational Site Number 1560005, Baotou, 014010, China|Investigational Site Number 1560042, Beijing, 101199, China|Investigational Site Number 1560053, Hangzhou, 310009, China|Investigational Site Number 1560051, Hefei, 210011, China|Investigational Site Number 1560011, Hunan, 411100, China|Investigational Site Number 1560025, Meihekou, 135000, China|Investigational Site Number 1560055, Nanchang, 330006, China|Investigational Site Number 1560024, Nanjing, 210011, China|Investigational Site Number 1560020, Pingxiang, 337055, China|Investigational Site Number 1560031, Shandong, 250013, China|Investigational Site Number 1560030, Shandong, 250031, China|Investigational Site Number 1560012, Shanghai, 200040, China|Investigational Site Number 1560013, Shanghai, 200040, China|Investigational Site Number 1560004, Shanghai, 200065, China|Investigational Site Number 1560022, Shanghai, 200090, China|Investigational Site Number 1560041, Tianjin, 300052, China|Investigational Site Number 1560010, Wenzhou, 325027, China|Investigational Site Number 1560052, Wuhu, 241001, China|Investigational Site Number 1560034, Wuxi, 214000, China|Investigational Site Number 1560026, Xuzhou, 221006, China|Investigational Site Number 1560044, Yichun, 336000, China|Investigational Site Number 1560003, Zhengzhou, 450003, China|Investigational Site Number 1580006, Kaohsiung, 83301, Taiwan|Investigational Site Number 1580003, Taichung, 40705, Taiwan|Investigational Site Number 1580002, Taipei, 11217, Taiwan
URL: https://clinicaltrials.gov/show/NCT03770728

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details